The agency approved a Risk Evaluation and Mitigation Strategy (REMS) for both extended-release (ER) and long-acting (LA) opioids, highly potent drugs approved for moderate to severe, persistent pain that requires treatment for an extended period. The REMS measure is part of a federal initiative to address the ongoing issues and growing epidemic concerning prescription drug abuse, misuse, and overdose. The REMS introduces new safety measures meant to reduce risks and improve the safe use of ER/LA opioids, while also ensuring access to these medications when needed for patients who are in pain.

“Misprescribing, misuse, and abuse of extended-release and long-acting opioids are a critical and growing public health challenge,” said FDA Commissioner Margaret A. Hamburg, M.D. “The FDA’s goal with this REMS approval is to ensure that health care professionals are educated on how to safely prescribe opioids and that patients know how to safely use these drugs.” Key components of the ER/LA opioid analgesics REMS include prescriber training, updated medication guide and patient counseling document, and assessment/auditing.

The new ER/LA opioid REMS affects more than 20 companies that manufacture opioid analgesics, which will be required to make education programs available to prescribers based on an FDA Blueprint. Companies will likely provide educational grants to continuing education (CE) providers, who will, in turn, develop and deliver the training.

The REMS also mandates companies make FDA-approved patient education materials available with the safe use of these drugs and perform periodic assessments of the REMS implementation and program success in meeting its goals. The FDA will review assessments and may require additional elements to achieve the program’s goals.

“We commend the FDA for taking action to save lives by increasing access to prescriber education,” said Gil Kerlikowske, director of the Office of National Drug Control Policy. “Since day one, the Obama Administration has been laser-focused on addressing the prescription drug abuse epidemic and today’s action is an important contribution to this comprehensive effort.”

ER/LA opioid analgesics are widely prescribed medicines with an estimated 22.9 million prescriptions dispensed in 2011, said IMS Health, which provides services and information to the health care and pharmaceutical industries. Estimates reveal that more than 320,000 prescribers registered with the Drug Enforcement Administration (DEA) wrote at least one prescription for these drugs in 2011.

ER/LA opioid analgesics are associated with serious risks of overuse, abuse, misuse and death and the numbers continue to rise. According to the Centers for Disease Control and Prevention (CDC), 14,800 Americans died from overdoses involving opioids in 2008; 15,597 deaths were reported in 2009, which is an almost four-fold increase from 1999. “Misuse and abuse of prescription opioids is a complex problem and demands a holistic response,” said John Jenkins, M.D., director of FDA’s CDER’s Office of New Drugs. “The new REMS program is one component of a multi-agency, national strategy to address this important public health issue.”

It is expected that the first continuing education activities under the REMS will be offered to prescribers by March 1, 2013.

There is no mandatory requirement that prescribers take the training and no precondition to prescribing ER/LA opioids to patients; however, in April 2011, the Obama Administration endorsed a mandatory training program on responsible opioid prescribing practices as part of its comprehensive plan to address the epidemic of prescription drug abuse. The program, which would be linked to DEA registration by providers, would require legislative changes being pursued by the Administration.